Effect of Liraglutide on Heart Frequency in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01516255
First received: January 19, 2012
Last updated: August 30, 2012
Last verified: January 2012
  Purpose

This trial is conducted in the United States of America (USA). The aim of this trial is to investigate if liraglutide effects the QTc interval. Moxifloxacin (Avelox®) is administered as positive control.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Drug: liraglutide
Drug: placebo
Drug: moxifloxacin
Procedure: electrocardiogram (ECG)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Thorough QTc Evaluation of the Effect of Liraglutide on Cardiac Repolarization in Healthy Volunteers: A Randomized, Double-blind, Placebo-controlled, Two Period Crossover Study Followed by Open-label Moxifloxacin (Positive Control) Administration

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Maximum time-matched mean difference between the baseline subtracted QTci intervals [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • QTc at liraglutide tmax (time to reach maximum concentration) [ Designated as safety issue: No ]
  • Percentage subjects with QTc at least 450, 480 and 500 milliseconds [ Designated as safety issue: No ]
  • Moxifloxacin maximum time-matched mean change QTc and QTci [ Designated as safety issue: No ]
  • Cmax, maximum concentration of liraglutide [ Designated as safety issue: No ]
  • tmax, time to reach Cmax of liraglutide [ Designated as safety issue: No ]
  • Vitals signs: Blood pressure [ Designated as safety issue: No ]
  • Vital signs: Pulse [ Designated as safety issue: No ]
  • Serial electrocardiography [ Designated as safety issue: No ]

Enrollment: 64
Study Start Date: July 2006
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Double-blind / liraglutide Drug: liraglutide
0.6 mg daily for 7 days followed by 1.2 mg daily for 7 days followed by 1.8 mg daily for 7 days. Injected subcutaneously. Subjects are randomly allocated to two treatment sequences
Drug: placebo
Injected subcutaneously. Subjects are randomly allocated to two treatment sequences
Procedure: electrocardiogram (ECG)
24 hours serial ECG is collected before initial dose of 0.6 mg liraglutide, on the last dosing day of 1.2 mg liraglutide and on the last dosing day of 1.8 mg liraglutide
Placebo Comparator: Double-blind / placebo Drug: liraglutide
0.6 mg daily for 7 days followed by 1.2 mg daily for 7 days followed by 1.8 mg daily for 7 days. Injected subcutaneously. Subjects are randomly allocated to two treatment sequences
Drug: placebo
Injected subcutaneously. Subjects are randomly allocated to two treatment sequences
Procedure: electrocardiogram (ECG)
24 hours serial ECG is collected before initial dose of 0.6 mg liraglutide, on the last dosing day of 1.2 mg liraglutide and on the last dosing day of 1.8 mg liraglutide
Active Comparator: Open-label / moxifloxacin Drug: moxifloxacin
Following the double-blinded period and a wash-out period of 7 days, subjects are re-randomised to an open-label, parallel period where a single dose of 400 mg moxifloxacin (tablets) is administered as positive control
Procedure: electrocardiogram (ECG)
Six hours after moxifloxacin or placebo single dose, 1 hour serial ECG is collected
Placebo Comparator: Open-label / placebo Drug: placebo
Following the double-blinded period and a wash-out period of 7 days, subjects are re-randomised to an open-label, parallel period where single dose of oral placebo is administered
Procedure: electrocardiogram (ECG)
Six hours after moxifloxacin or placebo single dose, 1 hour serial ECG is collected

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy
  • Fasting plasma glucose within normal limits (80-100 mg/dl)
  • BMI (Body Mass Index): 20.0-29.0 kg/m^2 (inclusive)
  • Heart rate within the range of 50-90 beats per minute (inclusive)
  • Subject is judged to be in good health on the basis of their medical history, physical examination, ECG (electrocardiogram), and routine laboratory data

Exclusion Criteria:

  • Any clinically significant disease history, in the opinion of the investigator, of systemic or organ disease
  • Any clinically significant disease history, in the opinion of the investigator, of cardiovascular disease
  • Clinically significant abnormalities on any pre-study clinical examination or any abnormal laboratory measurements during screening
  • A family history of sudden cardiac death at age less than 50 years old
  • T-wave abnormalities
  • Individual or familial history of long QT Syndrome
  • Positive results on Screening for Hepatitis B surface antigen, Hepatitis C antibody or HIV (human immunodeficiency virus) antibody
  • Positive results on the urine drug and alcohol screen
  • Any regular use of prescription or nonprescription drugs or vitamins and herbal/nutritional supplements that cannot be stopped at screening
  • Any strenuous exercise (as judged by the investigator) from 4 days prior to randomisation and during the entire trial period
  • Blood donation, trauma or surgery with blood loss exceeding 500 ml within the last 2 months prior to dosing
  • Subject is a smoker, occasional smoker or has a history of smoking (or use of any tobacco) within the last 3 months
  • Excessive use of methylxanthine-containing beverages (more than 8 cups/day of coffee, tea, soda or chocolate)
  • Females who are pregnant, breastfeeding, intend to become pregnant within the next 3 months, or who are judged to be using inadequate contraceptive measures
  • A history (within the last 2 years) of drug or alcohol abuse
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01516255

Locations
United States, North Dakota
Novo Nordisk Clinical Trial Call Center
Fargo, North Dakota, United States, 58104
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Milan Zdravkovic, MD, PhD Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01516255     History of Changes
Other Study ID Numbers: NN2211-1644
Study First Received: January 19, 2012
Last Updated: August 30, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Liraglutide
Glucagon-Like Peptide 1
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Hypoglycemic Agents
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on September 11, 2014